NCT02014194

Brief Summary

Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

November 25, 2013

Last Update Submit

January 23, 2018

Conditions

Keywords

Attentional BiasAttentional Bias modification treatment

Outcome Measures

Primary Outcomes (1)

  • Percentage of reduction of attentional bias

    Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10.

Secondary Outcomes (1)

  • Reduction of anxiety symptoms

    Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)

Study Arms (2)

attentional bias modification, placebo

PLACEBO COMPARATOR

Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). There are two arms with 15 OCD patients each one.

Behavioral: attentional bias modification treatment

attentional bias modification, active group

ACTIVE COMPARATOR

Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms).

Behavioral: attentional bias modification treatment

Interventions

The attentional bias modification treatment is a behavioral computerized program (software e-prime)

attentional bias modification, active groupattentional bias modification, placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • health controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo Medical School

São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Phd

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 18, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations